BioCryst Achieves Reimbursement for ORLADEYO Across all Major European Countries

About this update from Biocryst Pharmaceuticals, Inc.

ORLADEYO® (berotralstat) now reimbursed in the Netherlands RESEARCH TRIANGLE PARK, N.C. , June 06, 2025 (GLOBE NEWSWIRE) -- BioCryst Pharmaceuticals, Inc. (Nasdaq: BCRX) today announced that, following a positive recommendation from the Zorginstituut Nederland, ORLADEYO® (berotralstat) has been approved for the routine prevention of hereditary angioedema (HAE) attacks in patients aged 12 years and older. This reimbursement approval in the Netherlands marks national reimbursement for ORLADEYO across all major European countries, providing HAE patients with access to the first oral, once-daily preventive therapy. “From day one, our mission has been to bring ORLADEYO to as many people living with hereditary angioedema as possible. Securing reimbursement in the Netherlands is a proud moment for our team as it means that patients and physicians across all major European countries now have access to a modern, oral prophylactic option to help prevent HAE attacks. This is a great day for the HAE community and for the future of treatment,” said Abid Karim , general manager of Europe at BioCryst. This decision in the Netherlands follows the European Commission marketing authorization of ORLADEYO in April 2021 . To date, ORLADEYO is commercially available in more than 30 countries. About ORLADEYO ® (berotralstat) ORLADEYO® (berotralstat) is the first and only oral therapy designed specifically to prevent attacks of hereditary angioedema ( HAE) in adult and pediatric patients 12 years and older. One capsule of ORLADEYO per day works to prevent HAE attacks by decreasing the activity of plasma kallikrein. U.S. Indication and Important Safety Information INDICATION ORLADEYO® (berotralstat) is a plasma kallikrein inhibitor indicated for prophylaxis to prevent attacks of hereditary angioedema ( HAE) in adults and pediatric patients 12 years and older. Limitations of use The safety and effectiveness of ORLADEYO for the treatment of acute HAE attacks have not been established. ORLADEYO should not be used for the treatment of acute HAE attacks. Additional doses or dosages of ORLADEYO higher than 150 mg once daily are not recommended due to the potential for QT prolongation. IMPORTANT SAFETY INFORMATION An increase in QT prolongation was observed at dosages higher than the recommended 150 mg once-daily dosage and was concentration dependent. The most common adverse reactions (≥10% and higher than placebo) in patients receiving ORLADEYO were abdominal pain, vomiting, diarrhea, back pain, and gastroesophageal reflux disease. A reduced dosage of 110 mg taken orally once daily with food is recommended in patients with moderate or severe hepatic impairment (Child-Pugh B or C). Berotralstat is a substrate of P-glycoprotein (P-gp) and breast cancer resistance protein. P-gp inducers (eg, rifampin, St. John’s wort) may decrease berotralstat plasma concentration, leading to reduced efficacy of ORLADEYO. The use of P-gp inducers is not recommended with ORLADEYO. ORLADEYO at a dose of 150 mg is a moderate inhibitor of CYP2D6 and CYP3A4. For concomitant medications with a narrow therapeutic index that are predominantly metabolized by CYP2D6 or CYP3A4, appropriate monitoring and dose titration is recommended. ORLADEYO at a dose of 300 mg is a P-gp inhibitor. Appropriate monitoring and dose titration is recommended for P-gp substrates (eg, digoxin) when coadministering with ORLADEYO. The safety and effectiveness of ORLADEYO in pediatric patients

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